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Multifunctional Magnetic Resonance (MR) for Radiotherapy Planning in Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Royal Marsden NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Institute of Cancer Research, United Kingdom
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01006564
First received: November 2, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

To determine if functional MRI methods will aid planning of a radiation dose boost within the prostate in patients with prostate cancer potentially improving safety and efficacy.


Condition Intervention
Prostate Cancer
 Other: Imaging Investigations (not radiation)
Other: Other

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
Official Title: Multifunctional MR for Radiotherapy Planning in Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • Comparison of dose distributions produced by rival radiotherapy plans judged using radiobiological model predictions of Tumour Control Probability (TCP) and Normal Tissue Complication Probability (NTCP). [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of reproducibility of registration algorithms for mapping functional MR data acquired before hormone therapy to MR anatomical data acquired after hormone therapy and prior to radiotherapy. [ Designated as safety issue: No ]
  • Comparison of reproducibility of registration of functional and MR data with computed tomography (CT) data using gold seed registration, assessing reproducibility and positioning issues. [ Designated as safety issue: No ]
  • Comparison of image quality, registration reproducibility and gland distortion of internal and external imaging coils for MRI image acquisition and registration of the prostate. [ Designated as safety issue: No ]
  • Comparison of dose distributions produced by rival radiotherapy plans judged using three standard dose-volume constraints for targets and normal tissues and careful examination of the 3D dose distribution. [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Imaging Investigations (not radiation)
    Pre-hormone therapy MRI scans will be performed as an adjunct to the patients' staging MRI scan; post hormone MRI will be done wholly for research purposes.
    Other: Other
    Insertion of gold seeds into prostate for image registration.
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hormone therapy naive patients planned to be treated by radical radiotherapy after 3-6 months of androgen suppression
  • Patients with low-high risk histologically confirmed localised disease are eligible, with WHO performance status 0-1.

Exclusion Criteria:

  • Patients unsuitable for functional MRI of the prostate or gold seed fiducial marker insertion (e.g. patients unable to tolerate endorectal MRI examination).
  • No prior pelvic radiotherapy or radical prostatectomy, previous androgen therapy, patients unsuitable for radical radiotherapy, life expectancy <10 years, previous active malignancy within last 5 years, co-morbid conditions likely to impact on the advisability of radical radiotherapy, full anticoagulation, other exclusions to MRI (e.g. hip prosthesis or fixation, claustrophobia, ferromagnetic implants).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006564

Contacts
Contact: Dr Nandita deSouza 02086613289 nandita.desouza@icr.ac.uk

Locations
United Kingdom
Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Institute of Cancer Research, United Kingdom
Investigators
Principal Investigator: Dr Nandita deSouza CRUK Clinical Magnetic Resonance Research Group
  More Information

No publications provided

Responsible Party: Dr Nandita deSouza, Institute of Cancer Research
ClinicalTrials.gov Identifier: NCT01006564     History of Changes
Other Study ID Numbers: CCR3121
Study First Received: November 2, 2009
Last Updated: November 2, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Marsden NHS Foundation Trust:
Magnetic Resonance Imaging
Prostate Cancer
Magnetic Resonance Spectroscopy
Radiotherapy planning

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013